Autoimmune Hepatitis: When First Line Therapy Does Not Work

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1 Autoimmune Hepatitis: When First Line Therapy Does Not Work John M. Vierling, M.D., F.A.C.P. Professor of Medicine and Surgery Chief of Hepatology Director of Advanced Liver Therapies Baylor College of Medicine St. Luke s Hospital System Houston, Texas

2 Autoimmune Hepatitis (AIH) Definition: Syndrome of progressive hepatitis characterized by loss of tolerance to hepatic autoantigens that results in: Hepatocellular necroinflammation Autoantibodies: non-organ, non-species-specific Hypergammaglobulinemia and/or IgG Non-pathognomic histopathology Responsiveness to immunosuppressive medications

3 Autoimmune Hepatitis Classification Based on Autoantibodies Types 1 (95-97%) 2 (3-5%) AutoAbs ANA &/or SMA (f-actin ELISA) SLA/LP panca LC-1 ASGPR LKM1 SLA/LP LKM3

4 Autoimmune Hepatitis: Diagnosis Requires a Liver Biopsy Characteristic Feature Interface Hepatitis = Interface Hepatitis

5 Autoimmune Hepatitis Revised Scoring System of the International Autoimmune Hepatitis Group* Gender Female +2 HLA DR3 or DR4 +1 AP:AST (or ALT) ratio >3 < Immune disease Thyroiditis, colitis, others +2 -globulin or IgG level above normal > < Other markers Anti-SLA, actin, LC1, panca +2 ANA, SMA, or anti- LKM1 titers >1:80 1:80 1:40 <1: Histological features Interface hepatitis Plasmacytic Rosettes None of above Biliary changes Other features AMA Positive -4 Treatment response Complete Relapse Viral markers Positive Negative Drugs Yes No Pretreatment aggregate score: Definite diagnosis >15 Probable diagnosis Alcohol <25 g/day >60 g/day *Adapted from Alvarez F, Berg PA, Bianchi FB, et al. J. Hepatology 1999;31: Post-treatment aggregate score: Definite diagnosis >17 Probable diagnosis 12-17

6 Differential Diagnostic Dilemmas Autoantibodies Observed in Other Diseases Disease ANA/SMA LKM1 LKM2 LKM3 SLA/LP Acute Hepatitis Chronic HCV 20-25%+ 0-88% 80% + HBV-HDV 13% Alcoholic Hepatitis Wilson Disease 75%+ Common* *Acute phase reaction normalizes ceruloplasmin concentration!! Test [Cu]: 24 hour urine (>100 g) & hepatic (250 g/g dry wt)

7 Autoimmune Hepatitis Requires a Biopsy Centolobular Inflammation without Interface Hepatitis Centrolobular inflammation: 66% AIH presenting as ALF

8 2002 AIH Treatment Goals Definition of Remission Reduce mortality, symptoms Reduce AST and ALT to X ULN Histology: Confine inflammation to portal tracts Eliminate interface hepatitis Slow progression to cirrhosis Minimize immunosuppression to maintain remission Minimize serious adverse events

9 Probability of Cirrhosis During Steroid Therapy 100 Percent Probability During treatment During follow-up After treatment Duration of Therapy (Years) Czaja A, 2003

10 2010 AIH Treatment Goals New Concept of Remission Prevent progression and OLT Relieve symptoms Normalize ALT <19 U/L for women <30 U/L for men Histology: Eliminate portal lymphoplasmacytic inflammation Eliminate interface hepatitis Prevent progression to cirrhosis Use combinations of immunosuppressive drugs to Inhibit immunopathogenetic mechanisms at multiple sites Minimize adverse events

11 Autoimmune Hepatitis Frequency of Progression After Remission Using Definition in 2010 AASLD Guideline 4% Lack of Progression During Remission 96% Muratori L: Hepatology.2011; 52: 1857

12 Autoimmune Hepatitis Probability of Survival During Steroid Therapy Percent Probability No cirrhosis Cirrhosis during or after therapy Cirrhosis at presentation Duration of Therapy (Years) Czaja A, 2003

13 Autoimmune Hepatitis Options for Immunosuppression Vierling JM: Curr Gastroenterol Rep. 2012;14:25-36.

14 Autoimmune Hepatitis Clinical, Biochemical and Histological Remission During Steroid Therapy Percent Remission Czaja A, Duration of Therapy (months) Clinical Remission Biochemical Remission Histological Remission

15 Autoimmune Hepatitis Prospective, Double-Blind, Randomized, Controlled Trial Budesonide + Aza vs Prednisone + Aza Manns MP, et al. Gastroenterology 2010; 139:

16 Autoimmune Hepatitis in Pregnancy Fertility due to secondary amenorrhea Treatment not contraindicated Prednisone alone safe Safety of prednisone + azathioprine less clear Risk to fetus Prematurity (30%) Low birth rate (35%) C-section (26%) Risk of flare post-partum Complications of PVHTN due to expanded blood volume, intensified hyperdynamic circulation

17 Autoimmune Hepatitis Relapse of AIH After Withdrawal of Therapy Increased Probability of Cirrhosis and Need for OLT Montano-Loza AJ et al. Liver Int 2007; 27:

18 Autoimmune Hepatitis Alternative Immunosuppression to Achieve Remission Vierling JM: Curr Gastroenterol Rep. 2012;14:25-36.

19 Autoimmune Hepatitis Estimated Frequency of Remission Using 2002 vs AASLD Guidelines Definitions 27% Remission 73% 40% Remission 60% 2002 AIH Practice Guideline 2010 AIH Practice Guideline Muratori L: Hepatology.2011; 52: 1857

20 Corticosteroids Ursodeoxycholic acid IVIG, HuOKT3, ALG, ATG Hu-Max-CD4, Efalizumab, Enlimomab Abetacept, Belatacept, Alefacept, Anti-CD154 (hu5c8) Anti-CD137, Anti-CD4 Alemtuzumab APC T Cell T Cell T Cell B7-CD28 Foreign antigen Autoantigen Alloantigen Cell Cycle Phase Cyclosporine Tacrolimus IL-2 Sirolimus Basiliximab Daclizumab IL-2R G0 G1 S Azathioprine, 6-MP, 6TP Mycophenolate mofetil Leflunomide FK778 IVIG, HuOKT3, ALG, ATG Alemtuzumab T Cell T Cell T Cell T Cell Mitosis Leflunomide Efalizumab Enlimomab FTY720 Natalizumab IVIG Chemokine inhibitors Transendothelial Migration and Tissue Injury Imfliximab Adalimumab Etanercept Rituximab Alemtuzumab Vierling JM & Flores P: Clin Liver Dis 2002; 6: Vierling JM: Semin Liv Dis 2005; 25: Vierling JM: Liver Immunology 2nd Ed, 2007

21 Mycophenolate Mofetil Treatment in AIH Patients Refractory or Intolerant to Conventional Therapy Sharzehi K, et al. Can J Gastroenterol 2010; 24:

22 Allopurinol to Optimize Thiopurine Metabolites in AIH 6 TGN 6 MMP De Boer YS, et al. Aliment Pharmacol Ther 2013; 37:

23 Cyclosporine N Regimen Response Comments 15 patients 32 patients 3 groups 2 CsA alone. 1 with steroids/aza CsA 6 months AZA/Pred 1 month CsA stopped 19 patients CsA 2-5mg/kg/d 100% remission 3 relapses responded to CsA dose adjustment 100% remission No relapses Of the patients who continued therapy 100% response 6 patients CsA 3 mg/kg/d 5 of 6 6 patients CsA 2-4 mg/kg/d 4 of 5 Adapted from Vierling JM, Flores PA. Clin Liver Dis; 2002(6):

24 Fernandes et al. Am J of Gastro. 1999;94(1): Cyclosporine

25 Tacrolimus ALT levels P<0.05 P<0.05 P<0.05 Larsen et al. W J of Gastro. 2007;12(23):

26 Weiler-Normann C, et al. J Hepatol 2013; 58: Infliximab Rescue

27 Autoimmune Liver Diseases Excellent Survivals Post-OLT UNOS Database Figure 1. Post-OLT Patient Survival PBC 12% AILDs 26% PSC AIH 8% 6%* All Other 74% Patient Survival (%) PBC AIH ETOH HCV + HCV ETOH Years Post-OLT Ilyas J, O Mahony C, Vierling. Best Pract Res Clin Gastro; 2011

28 Allograft Loss After OLT Impact of Recurrent Diseases HCV PSC 10% after 13.7 years AIH Crypto FHF FHF Rowe IA et al. Transplant Int 2008; 21:

29 Autoimmune Hepatitis Practical Summary Diagnosis of AIH based on inclusion AND exclusion of diseases mimicking biochemical, serological and histopathological features of AIH Wilson disease DILI HCV infection without a positive anti-hcv Diagnosis aided by response to 4 week course of induction steroid monotherapy If AIH confirmed, Convert to budesonide if non-cirrhotic Add azathioprine: if intolerant to azathioprine, consider 6-MP or MMF If generation of 6-TG inadequate, consider allopurinol If remission not achievable with steroids and azathioprine: Switching azathioprine to mycophenolic acid futile Alternative therapy with cyclosporine, tacrolimus, sirolimus, anti-tnfα agents Role of ursodexoycholic acid unclear If remission achieved, continue maintenance therapy indefinitely

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